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UP - Quality Control

Pharmacy (University of Bohol)

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1. This type of analysis deals with the determination of the Acidimetry is the direct or residual titrimetric
total class of plant principles analysis of bases using an accurately measured volume of
A. Ultimate analysis acid
B. Proximate analysis Iodimetry is a direct procedure (note: DImetry for
C. Bioassay Direct). It is used in the analysis of reducing agents such as
thiosulfates and arsenates by the use of standard solutions of
Proximate assay is the determination of the amount iodine
of organic constituent which may be present in any Alkalimetry is the direct or residual titrimetric
vegetable drug or plant to which its activity is attributed. It is analysis of acids using an accurately measured volume of
concerned with the analysis of a group of constituents, e.g. bases
alkaloids
Ultimate analysis deals with the study of a specific
plant constituent, e.g. specific alkaloid like atropine 4. Phenolphthalein when added to a solution of HCl produces
Biological assays measure the actual biological A. Pink color
activity of a given sample. They are conducted by B. No color
determining the amount of a preparation of unknown C. Yellow color
potency required to produce a definite effect on suitable test D. Blue color
animals or organs under standard conditions
Phenolphthalein is used when a weak acid is titrated
with a strong alkali. It exhibits no color at a pH of 8.0 and a
2. Gram molecular weight of solute in one liter of solution red color at a pH of 10, while between these pH values the
A. Normality color undergoes a transition from one shade to another. In
B. Molarity summary:
C. Molality ACID – no color
D. % w/w BASE – pink

Molarity is an expression of concentration of

solution in terms of moles per liter 5. This type of analysis depends on sample weight
Normality is a concentration expression and is calculations
defined as the number of equivalents of solute per liter A. Volumetric analysis
(equiv/L) or milliequivalents per mL of solution (mEq) B. Gravimetric analysis
Molality is defined as the number of moles of solute C. Colorimetric analysis
per 100 grams of solvent D. Turbidimetric analysis
Percentage weight-in-weight indicates the number
of parts by weight of active ingredient that are contained in Gravimetric analysis is the measurement of weight
the total weight of the solution considered as 100 parts of a substance in a sample from the weight of a chemically
weight equivalent amount of some other substance

3. Redox reaction wherein the sample is made to liberate 6. A burette with a glass stopcock cannot be used for
iodine which is then titrated with standard solution of sodium A. Acids
thiosulfate is B. Alcohol
A. Acidimetry C. Bases
B. Iodometry D. Salts
C. Iodimetry
D. Alkalimetry Burettes are graduated glass tubes with uniform
bore throughout the whole length used in the measurement
Iodometry is an indirect procedure, i.e., the sample of variable quantities of liquids. A burette with a rubber
is reduced withexcess KI and an equivalent amount of iodine stopcock is usually used when employing a base as titrant
is produced and the iodine formed is titrated with a standard
solution of sodium thiosulfate. This is used in the analysis of
oxidizing agents such as ferric cupric salts and “available”
chlorine

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7. The process by which the exact concentration is column under high pressure. The advantages of HPLC as
determined is compared to classical chromatographic methods are greater
A. Neutralization speed, precision, accuracy and ease of operation. Because of
B. Standardization these, it is widely used in the pharmaceutical industry
C. Titration

Standardization is the determination of the molarity 10. Used to measure water content of raw materials
or normality of a solution. This may be accomplished by the A. Karl Fischer titrimeter
use of another standard solution known as a secondary B. Pycnometer
standard or by the use of carefully weighed sample of a C. Platform balance
substance of known purity which is termed as primary D. NOTA
standard
Neutralization is the chemical process in which an The titrimetric determination of water is based upon
acid (proton donor) reacts with a base (proton acceptor). The the quantitative reaction of water with an anhydrous solution
products of a neutralization reaction in aqueous solution are of sulfur dioxide and iodine in the presence of a buffer which
water and a salt, depending upon the acid and base use in the reacts with hydrogen ions, this original solution is known as
reaction Karl Fischer reagent. The composition of Karl Fischer reagent
Titration is the act of adding and measuring the is as follows:
volume of titrant used in the assay 125 g Iodine
670 mL methanol
170 mL pyridine
8. What does the ash content naturally occurring in a crude Sulfur dioxide
drug represent?
A. Organic salts For determination of trace amounts of water (less
B. Inorganic salts than 1%), sodium tartrate may be used as convenient water
C. Cellulose reference standard. The test specimen may be titrated
directly or may be carried out by a residual titration
The ash content of a crude drug is generally taken to procedure
be the residue remaining after incineration. It usually
represents the inorganic salts naturally occurring in the drug
and adhering to it but it may also include inorganic matter 11. Considered as best cleansing agent for glasswares
added for the purpose of adulteration. An ash determination A. Sodium dichromate in sulfuric acid
furnishes a basis for judging the identity and cleanliness of a B. Nitric acid
drug and gives relative information relative to its C. Synthetic detergent
adulteration with inorganic matter D. NOTA
The residue that remains undissolved after
successive treatment of crude drug with boiling acid and An effective method of removing organic matter
alkali consists mainly of cellulose. The determination of from glass without heating is by treatment with chromic acid
crude fiber is of considerable importance in the examination cleansing mixture which is composed of:
of certain drugs, especially those which are usually being Sodium dichromate – 200g
adulterated Water – 100mL
Sulfuric acid – 1500mL

9. The most current apparatus being used for the

determination of drug mixtures and components 12. The Volhard method of analysis makes use of this
A. HPLC indicator
B. GC A. Methyl red
C. NMR B. Methyl orange
D. Mass spectrometer C. Ferric ammonium sulphate
D. Potassium chromate
HPLC can stand for high performance liquid
chromatography due to extremely high efficiencies (as many The Volhard method is based on the complete
as 50,000 plates/m) attainable or for high pressure liquid precipitation of insoluble silver slats from nitric acid solution
chromatography because of the high pressures (1000 to 3000 by the addition of excess standard silver nitrate solution to a
psi) required. The mobile phase is forced through the packed soluble salt, and the determination of the amount of silver

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nitrate solution in excess by residual titration with standard 16. Nephelometry measures light that is
ammonium thiocyanate using ferric ammonium sulphate as A. Reflected
indicator B. Absorbed
The indicator used in the Mohr method of analysis is C. Transmitted
potassium chromate. Both the Volhard method and the D. Absorbed by particles of a suspension
Mohr method are used in volumetric precipitation
Nephelometry is based on the measurement of the
brightness of the light reflected by a cloud of finely dissolved
13. Primary standard used in the standardization of particles suspended in liquid
potassium permanganate solution Measurement of light that is absorbed is called
A. Sodium oxalate turbidimetry
B. Sodium carbonate
C. Potassium biphthalate
D. Potassium sulphate 17. Present is a spectrophotometer but not in a colorimeter
A. Prism
Potassium permangate solutions can be B. Lamp house
standardized easily and it retains its concentration over long C. Cell compartment
periods of time when proper precautions are observed in its D. AOTA
preparation and preservation. Sodium oxalate is the best
standard to use in the standardization since it can be A spectrophotometer is an instrument which is
obtained in a very pure condition. The reactions of capable of isolating monochromatic radiation. The desired
permanganate in solution are rapid. It also serves as an wavelength is isolated by using a prism or grating and
indicator in titrations where it is used since very slight in auxiliary mirrors and slits, which, collectively form the
permanganate imparts to solutions a distinct pink color monochromator of the instrument. A colorimeter or filter
photometer isolates several wavelengths of radiant energy
by using a filter
14. Acid insoluble ash is the part of the total ash which is
insoluble in
A. Dilute sulfuric acid 18. Official diluted alcohol contains _____% alcohol
B. Dilute hydrochloric acid A. 10%
C. Dilute nitric acid B. 50%
D. Acetic acid C. 70%
D. 80%
Acid-insoluble ash is the part of the total ash which
is insoluble in diluted hydrochloric acid. The diluted HCl Diluted alcohol is a mixture of alcohol and water
dissolves the calcium carbonate, alkali chlorides, etc. Leaving containing not less that 41% and not more than 42% by
an acid insoluble residue that consists almost entirely of silica weight, corresponding to not less than 48.4% and not more
derived from the soil adhering to the drug than 49.5% by volume at 15.56°C of ethanol

15. Determination of most of the official drugs containing 19. Method used is in the assay of sulphonamides
calcium and zinc is done by A. Gravimetric
A. Gravimetry B. Acid-base titration
B. EDTA method C. Diazotization
C. Bioassay D. Gasometric
D. Non-aqueous titrimetry
The assays of the sulfa drugs and other compounds
Historically, the quantitative analysis of inorganic containing an arylamino group are usually conducted by
pharmaceutical products containing metal ions was diazotization with sodium nitrite
performed using gravimetric methods. With the introduction
of EDTA, as new procedure has evolved for metal
determination using metal ions to form a water soluble
stable complex or chelate compound. The reaction is rapid
and quantitative with such polyvalent ions such as aluminum,
bismuth, calcium, copper, mercury, manganese and zinc

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20. Vitamin B12 and calcium pantothenate are assayed using Ferric ammonium sulfate TS is used in direct and
A. Iodometry residual titrations employing standard ammonium
B. Microbiological turbidimetry thiocyanate solutions. The thiocyanate reacts with the silver
C. Iodimetry or mercuric ions present to form a white precipitate of silver
D. Fluorometry or mercury thiocyanate but as soon as all the silver or
mercury has been precipitated, the thiocyanate reacts with
The turbidimetric method depends upon the ferric ammonium sulfate to form a red ferric thiocyanate, the
inhibition of growth a microbial culture in a uniform solution first appearance of a red color marks the endpoint of the
of antibiotic in a fluid medium that is favourable to its rapid reaction
growth in the absence of antibiotic. In this method, the
activity of the biological agent is determined by measuring
the turbidity produced in a series of antibiotic dilutions 24. The indicator in EDTA direct titration against carbon
containing a microbiological culture. The microorganism carbonate is
used in the assay of calcium pantothenate is A.Thymol blue
LACTOBACILLUS PLANTARUM and vitamin B12 is the B. Hydroxynapthol blue
microorganism LACTOBACILLUS LEICHMANII. The greater C. Methyl red
the turbidity, the lesser the activity of the antibiotic D. Methylene blue

Hydroxynaphthol blue is used as the indicator

21. The ester value determination of substances is applicable against calcium carbonate. After all the calcium has been
to the following except complexed with the EDTA, the colored calcium indicator
A. Fats complex gives up the calcium to EDTA, liberation the free
B. Volatile oils uncomplexed indicator which is blue
C. Alcohols
D. Fatty oils
25. The oil content of peppermint spirit can be measured by
The ester value or ester number is defined as the using
number of milligrams of potassium hydroxide required to A. Cassia flask
saponify the esters in 1 gram of a fatty or volatile oil, fat, wax, B. Babcock bottle
balsam, resin or similar substance C. Wash bottle
D. Florence flask

22. Ceric sulfate is The estimation of the volatile oil content of certain
A. Reducing agent official spirits is based upon the separation of the volatile oil
B. Oxidizing agent by means of an immiscible solvent and measurement of the
C. Precipitating agent volume of oil. The babcock bottle, the neck of which is
D. Complexing agent calibrated into eight main divisions of 0.2 mL each is used for
the assay of volatile in spirits
A solution of ceric sulfate in diluted sulfuric acid is a The cassia flask is a glass flask of about 100mL
strong oxidizing agent and considerabley more stable than capacity with a long, narrow neck graduated to 10mL in 0.1
standard permanganate solution, provided sufficient sulfuric divisions. It is used in the assay of aldehydes and ketones by
acid is present to prevent hydrolysis and precipitation of bisulfite method
basic salts. The primary standard used for the Wash bottles are used to wash down hanging drops
standardization of ceric sulfate in cerimetric methods of standard solution clinging to the tip of the burette or inner
analysis is arsenic trioxide. Four equivalents of ceric sulfate is wall of the vessel
needed to oxidize one mole of arsenic trioxide

26. The term used to designate results that are close to one
23. Ferric ammonium sulfate is employed as an indicator in another is
volumetric precipitation method if the titrant is A. Approximate
A. 0.1 N silver nitrate B. Precision
B. 0.1 N sodium hydroxide C. Accuracy
C. 0.1 N sodium thiocyanate D. Exact
D. Sodium tetraphenyl boron

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Precision is a measure of reproducibility of data Buffer solutions have the property of resisting
within a series of results. Results within a series which agree changes in pH when acids or bases are added to them. This
closely to one another are said to be precise property of resisting pH changes usually results from the
Accuracy is used to denote the agreement of an presence of a pair of chemicals, often referred to as a buffer
experimental result or the agreement of the mean value of a pair, which consists of either a weak acid and some salt of the
series of experimental results with the true value weak acid or a base and some salt of a weak base

27. The theory or principle which deals with the behaviour of 30. Application of potentiometry
a difficulty soluble salt in a saturated solution is A. Biologic assay
A. Solubility product principle B. pH determination
B. Theory of ionization C. Qualitative analysis
C. Reversible reaction D. Identification test
D. A and B
Potentiometry or the measurement of potential, is
The principle is stated as follows: The product of the important in chemical analysis because the potential
concentration of the constituent ions in a saturated solution developed by a particular electrode immersed in a solution is
of a difficultly soluble salt for any given temperature is dependent on the presence of some entity in the solution
practically a constant, each concentration being raised to a and its concentration in the solution. Because of the relation
power equal to the relative number of ions supplied by one between electrical potential and pH, titrations involving acid
molecule of the salt upon dissociating and base lend themselves to the determination of endpoint
by potentiometric means

28. Gas chromatography is utilized in the separation and

identification of: 31. Used to locate spots of radioactive elements in
A. Volatile liquids in a mixture chromatography
B. Amino acids A. Direct inspection
C. Blood components B. Spraying with reagents
D. Alkaloids C. Microscope
D. Geiger-Muller counter
To date gas-solid-chromatography has been largely
limited to the analysis of gases such as oxygen, nitrogen, The Geiger-Muller counter is efficient particularly
hydrogen, nitrous oxide and such low boiling point for the detection of beta particles. When a radioactive atom
compounds such as methane and ethane. In contrast, gas decays, it emits a particle or electromagnetic radiation or
liquid chromatography has had a much greater application in both, depending upon the mode of decay of the nucleus. It is
pharmaceutical analysis. Being most applicable to most the radiation resulting from the decay of atoms which is
organic constituents which have measurable vapour pressure detected by the radiation measuring equipment
at the temperature employed

32. Koettsdorfer number is also

29. Complex organic compounds used to determine the end A. Ester number
point of a neutralization reaction is B. Saponification number
A. Buffer C. Hydroxyl number
B. Indicator D. Iodine number
C. Titrant
D. Analyte Koettsdorfer is the originator of the process, this is
why saponification number is sometimes called Koettsdorfer
Indicators have three uses: number. It is defined as the number of milligrams of
 To determine the endpoint of a neutralization potassium hydroxide required to neutralize the free acids and
reaction saponify the esters contained in 1 gram of fat, fatty or
 To determine the hydrogen ion concentration or pH volatile oil, wax, resin, balsam or other substance of similar
 To indicate that a desired change in pH has been composition
effected

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33. Content uniformity of tablets USP limits Flame photometry depends on the measurement of
A. 85-115% the intensity of light emitted by an element when subjected
B. 95-105% to high temperatures. It employs an emission measuring
C. 90-110% device and utilizes a gas air flame for excitation. The
D. 90-100% detection is limited to group 1A and 11A metals of the
periodic table which have a low lying electronic level. Sodium
Unless otherwise specified in the individual is the most active in the series with a detection limit of
monograph, the requirements for dose uniformity are met if 0.0002ppm and potassium is second with a detective limit of
the amount of the active ingredients in each of the 10 dosage 0.001ppm
units as determined from the weight variations or the
content uniformity method lies within the range of 85%-
115% of the label claim and the relative standard deviation is 37. Stationary phase in gas chromatography
less than or equal to 6% A. Gas
B. Liquid
C. Cellulose
34. Validation is a new quality assurance concept required D. Chromatogram
now in CGMP to be applied to
A. Manufacturing process Gas chromatographic methodology is divided into
B. Returned goods two classes depending on the nature of the stationary phase
C. Analytical methods since the mobile phase is always a gas. These are gas-solid
D. A and C chromatography, in which the stationary phase is a solid
adsorptive material, and gas liquid chromatography in which
Process validation is defined as “establishing the stationary phase is a thin layer of liquid, usually as a
documented evidence which provides a high degree of coating on the surface of an inert molecule
assurance that a specific process will constantly produce a
product meeting its predetermined specification and quality
characteristics.” It is the act of verifying that a procedure is 38. Steroids are usually separated by
capable of producing the intended result under all expected A. Ion exchange chromatography
circumstances B. Paper partition chromatography
C. Reversed phase chromatography
D. NOTA
35. Type of QC equipment for measuring the absorbance of
substance between regions 200-750 nm Reversed phase chromatography is also based on
A. Colorimeter the partition phenomenon but as the name implies, the non-
B. UV-Vis spectrophotometer polar solvent is fixed to the paper or solid column material
C. Medium infrared and acts as the stationary phase and a polar solvent is used as
D. Near infrared the mobile phase. It is especially useful in the separation of
water insoluble substances such as steroids. However,
Molecules irradiated with ultraviolet (185 to 380 nm) steroids are identified using the spectrophotometric method.
or visible radiant energy (380 to 780 nm) abstract from the The assay is applicable to all pharmacopoeial steroids that
incident beam only that energy which will elevate selected possess reducing functional groups such as alpha-ketols.The
electrons in the molecule to certain permitted energy levels. measurements are determined at about 525nm
The absorption of radiant energy in the UV or visible region
involves only electronic transitions and more specifically, the
promotion of electrons in sigma, pi and n orbitals of organic 39. Content uniformity test is to be performed for all tablet
compounds products whose active ingredient is
A. 130mg or less
B. 324mg or less
36. The instrument used to measure sodium and potassium C. 500mg or less
quantitatively D. 50mg or less
A. Polarimeter
B. Refractometer Weight variation requirements may be applied
C. Spectrophotometer where the product is a liquid filled soft capsule or where the
D. Flame photometer product to be tested contains 50 grams or more of an active
ingredient, comprising 50% or more by weight of the dosage

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form unit. Uniformity with respect to their active ingredient, 43. The most commonly used matrix in pellet mixture
if present in lesser proportions, is demonstrated by content A. KBr
uniformity requirements. Content uniformity test is B. KI
performed for those products with 50mg or less of the active C. NaCl
ingredient D. CsI

Samples for IP determination can be prepared in the

40. Hexane is the best solvent for extracting form of solid, liquid or gas. Solid samples are prepared either
A. Resins as a KBr disk or in the form of a dispersion in mineral oil. A
B. Fats KBr disk is prepared by grinding the sample with KBr powder,
C. Volatile oils placing the mixture between a punch and die and applying
D. Acids pressure of about 50,000 psi.

Solvent hexane is a good solvent for fats and fatty

acids. The hexane extractive is an index to the amount of fat 44. The type of cell used for volatile liquids in IP spectroscopy
present A. Demountable
B. Sealed
C. ATR groups
41. A tool for detecting variations in a process is the
A. Pie chart A common problem in the spectroscopy is due to
B. Bar graph the volatility when the spectrum of volatile sample is
C. Quality control chart recorded it becomes progressively weaker because
D. T chart evaporation takes place during the recording period. Liquids
with boiling points below 100 degrees should be recorded in
Quality control charts have been employed for solution or in a short path length (0.01 mm) sealed cell.
various pharmaceutical operations and may be used as an aid Sealed cells have the advantage of a cell path length which is
in controlling and analyzing physical, analytical, chemical or accurately and permanently known
biological parameters. Any measurement that could form the
basis of acceptance or rejection of the product would be
amenable to surveillance via the control chart 45. In tablet friability, the result is considered acceptable for
most products if the maximum weight loss is not more than
A. 1%
42. When the chart makes use of date from measurable B. 2%
characteristics, it is called C. 4%
A. P chart D. 5%
B. Attribute chart
C. Variable chart Friability is measured using a Roche friabilator which
D. T chart is designed to evaluate the ability of a tablet to withstand
abrasion in packaging, handling and shipping. A number of
These are two basic types of QC charts: based on tablets are weighed and placed in the tumbling apparatus
variables and based on attributes. Variable charts are based where they are exposed to rolling and repeated shocks
on a continuous distribution of measurements that can in a resulting from free falls within the apparatus. After a number
sense measure degrees of effectiveness. of rotations the tablets are weighted and the loss in weight
Attribute charts refer to “go” or “no go” situation in indicates the ability of tablets withstand this type of wear.
which each sample inspected is tested to determine whether The maximum weight loss should not be more than 1%
it conforms to the requirements.
A quality control chart by variables of by attributes
developed on a basis of certain quality characteristics serves 46. Dissolution testing is conducted using a dissolution
as an aid in keeping the product in control medium heated at
A. 37°C
B. 40°C
C. 32°C
D. 45°C

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Dissolution is the process by which a solid of only A chromophore may be defined as a functional
fair solubility characteristics goes into solution. Since drug group which absorbs radiant energy in the UV or visible
solubility is temperature dependent, its careful control regions of the spectrum. Some examples are ethylene,
during the dissolution process is very important and should acetylene, ketones, organic acids and azomethines
be maintained within 0.5 degrees. Generally, a temperature
of 37 degrees is always maintained during dissolution
determinations 50. The volume of the mobile phase required to elute the
zone maximum from the column is
A. Retention volume
47. For the disintegration test of enteric coated tables, the B. Migration behaviour
immersion fluid is C. Retention time
A. Water D. Flow rate
B. Oil E. Molar volume
C. Phosphate
D. Simulated gastric juice Retention time and retention volume are terms used
in gas chromatography. Retention volume is defined as the
Complete disintegration is defined as that state in volume of carrier gas necessary to carry an average molecule
which any residue of the unit, except fragments of insoluble of the component from the point of injection to the detector.
coating or capsule shell, remaining on the screen of the test It is found by multiplying the retention time by the gas flow
apparatus is a soft mass having no palpably firm core. It is rate of the carrier gas. Retention time is defined as the time
performed on tablets and capsules except those that are required by an average molecule of component to pass from
intended for uses as troches or are to be chewed or are the injection point through the column to the detector
designed as modified dosage forms. Water maintained at 35-
39°C is usually used as the disintegration medium except for
enteric coated tablets wherein the medium used is simulated 51. The solvent for NMR should not contain
gastric fluid maintained at 35-39°C A. Carbon
B. Chloride
C. Hydrogen
48. To measure optical activity of a sample, the instrument D. Sulfur
used is
A. Polarimeter The most frequently used atomic nuclei in nuclear
B. Refractometer magnetic resonance are the protons, hydrogen and carbon
C. Spectrophotometer (C13). It has been estimated that 90% of NMR work deals
D. Flame photometer with hydrogen and most of the remaining deals with carbon.
For spectral determination, a solid or liquid sample is first
Polarimeters permit the angle of rotation to be read placed in a suitable solvent free of protons (CCl4, CS2, etc)
off in degrees or fractions of a degree of a circle. Optically and then it is added to the NMR sample probe followed by
active substances possess the power of rotating the plane the reference standard, TMS (tetramethlysilane)
polarized light when the latter is passed through solutions
containing the sample.
The index of refraction of a chemical substance may 52. The solvent which is not used in IR spectroscopy
be defined as the ratio of the velocity of light in air to the A. Carbon disulfide
velocity of light in the medium. It is used in the B. Dimethyl formamide
determination of the identity and purity of drug products. C. Water
The instrument used to measure the refractive index is called D. Chloroform
refractometer
In the IR region of the electromagnetic region, water
cannot be used as a solvent because it strongly absorbs most
49. The term given to the functional group of an organic of the IR radiation, thereby obscuring absorption by the
molecule that absorbs maximum radiation in UV or IR region solute. Another good reason why water cannot be used is
A. Moiety that it would destroy the sodium chloride cells which hold the
B. Carbonyl sample
C. Chromophore
D. Nitrile

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53. The pH of a solution is usually measured by 56. Recall

A. Platinum electrode A. Is a function of the biological testing laboratory
B. Glass B. Should be filed by a dissatisfied customer
C. Mercury C. Damages the food reputation of a company
D. Calomel D. AOTA

The choice of the reference electrode involves In instances in which it is found by BFAD or by a
several considerations including reproducibility, permanency manufacturer that a marketed product presents a threat or a
and the temperature coefficient. The glass electrode is the potential threat to consumer safety, that product may be
most popular of all indicator electrodes for pH recalled or sought for return to the manufacturer from its
measurements. Because of the high resistance of glass, pH depth of distribution. The depth of recall or the level of
determinations must be made using an electronic device market removal or correction, depends upon the nature of
called a pH meter. A glass electrode consists of an outer glass the product, the urgency of the situation, and the depth to
tube containing about 0.1 N HCl which makes contact with a which the product has been distributed
silver, silver chloride electrode
The saturated calomel electrode is the most practice
choice of reference electrode for all round use and is the 56. Improperly sealed ampuls should be tested
most popular A. Leak
B. Visible particulate
C. Bacteria
54. The components of a blank used in the assay of a D. Pyrogen
substance are except
A. Solvent The leaker test is intended to detect incompletely
B. Reagent sealed ampuls so that they may be discarded. Leakersare
C. Indicator usually detected by producing a negative pressure within an
D. Analyte incompletely filled ampul, usually in a vacuum chamber,
while the ampul is entirely submerged in a deeply colored
Whenever, there is reason to believe that the dye solution (usually 0.5-1.0% methylene blue). Subsequent
reagents in the official procedure or the conditions under atmospheric pressure then causes the dye to penetrate an
which the analysis is performed may interfere or compete for opening, being visible after the ampul has been washed
a titrant or complement the titrant, a blank determination is externally to clear it of the dye. Vials and bottles are not
run so that any of the possible interference may be subjected to a leakers test because the rubber closure is not
appropriately corrected for. In the blank determination, the rigid
same procedure is followed except that there is no active
constituent
57. QC test that is performed exclusively on suspensions
A. Phase inversion
55. Testing program carried out to determine the shell life of B. Isoelectric point
the product C. Sedimentation rate
A. QC testing program D. NOTA
B. Validation testing program
C. Stability testing program Sedimentation and flocculation rates are properties
D. AOTA of suspension systems governed by the particle size, particle-
particle and the medium and the viscosity of the continuous
It is extremely important that the pharmaceutical phase. Sedimentation rate will be reduced by decreasing the
manufacturer accurately predict the shell stability of a new particle size, provide the particles are kept in a deflocculated
product from accelerated storage data because of the state. The rate of sedimentation will be an inverse function of
considerable economic advantage gained in marketing a new the viscosity of the dispersion medium
product as soon as possible after formulation. A sound
stability testing program is possible only if personnel are
skilled in employing these principles and if appropriate
equipment is available

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58. Method of stability testing wherein the product is stored 62. USP specifies that almost all measurement and tests that
in the proposed container closure system for marketing at a are temperature dependent must be conducted at
temperature specified on the label is called A. 20°C
A. Long term stability studies B. 25°C
B. Accelerated stability studies C. 30°C
C. Both A and B D. 10°C
D. NOTA
The USP specifies that unless otherwise specified,
Accelerated stability studies are also known as all temperature are expressed in centigrade and all
stressed studies. It is a method of testing employing measurement are made at 25 degrees C
validated method by which product stability may be
predicted by storage of a product under conditions that
accelerate change in a defined and predictable manner 63. The theoretical point at which equal amount of analyte
and titrant have reacted
A. End point
59. The trained, accurate observation that usually involves B. Stoichiometric point
the visual monitoring of an item at specified or random C. Neutralization
checkpoints D. Volumetric analysis
A. Inspection
B. Testing The stoichiometric point is also known as
C. Sampling equivalence point.
D. NOTA The end point is the point that the titration stopped.
There occurs a sudden change in some property of the
Testing involves the accurate measurement of reaction mixture, a change which is made apparent by the
characteristics and includes quantitative and qualitative use of indicators or electrometrcally
examination at specified or random checkpoints

60. A term in compleximetry used to indicate a

determination of a metal in the presence of another metal
A. Redox
B. Masking
C. Linking
D. Complexing

The masking agent itself is a compound capable of

entering a complexation reaction. The masking can be
accomplished by adjusting the pH of titration medium so
that it will be favourable for complexation of the metal using
determined. Examples of masking agents are
triethanolamine, thioglycols, potassium cyanide, ammonium
fluoride, ascorbic acid, citrates and tartrates

61. The most common quantitative method for the

determination of nitrogen in organic compounds is
A. Dumas
B. Kjeldahl
C. Parr
D. Nitrometer

The Kjeldahl method is applied widely in the analysis

of proteins of food, fertilizer, blood, etc

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PRACTICE SET 9. To remove stains of iodine, the most effective chemical

system is
1. Nuclear magnetic resonance is used for A. Calamansi
A. Radioisotopes B. Hydrogen peroxide
B. Irradiation C. Sodium thiosulfate
C. Identification of chemicals D. Ferric chloride
D. A and B
10. Potency of a 100mg tablet at expiry date
2. The sample is said to have a constant weight when the A. 90 mg
difference between the last consecutive weighing is not more B. 95 mg
than C. 105 mg
A. 0.0025% D. 110 mg
B. 0.025%
C. 0.25% 11. When the active drug is decreased by heating during
D. 2.5% processing the excess added is called
A. Manufacturing overage
3. USP acetylsalicylic acid tablets should be packaged and B. Stability overage
stored in C. AOTA
A. Well closed containers
B. Tightly closed container 12. To identify status of materials, _________ are pasted on
C. Light resistance the outer container
D. NOTA A. Colored stickers
B. Tables
4. If a sample of beeswax is found to have an acid number of C. Certificate
15.5 and a saponification value of 71.2, the ester value of the
sample is 13. The primary standard used for standardization of KMnO4
A. 86.7 in redox method of analysis is
B. 55.7 A. MgO
C. 90 B. ZnO
D. NOTA C. Na2CO3
D. CaCO3
5. The operating speed for paddle in dissolution apparatus
A. 100 rpm 14. The technique used when a sample is readily dissolved in
B. 150 rpm a solvent which can be evaporated leaving a thin film behind
C. 200 rpm A. KBr pellet
D. 50 rpm B. Nujol film
C. Cast film
6. The type of ash where the sulfuric acid is used D. Free standing film
A. Acid insoluble ash
B. Sulfurated ash 15. In process controls for tablets include the following,
C. Ignited ash except:
D. Loss on ignition A. Weight variation
B. Hardness and thickness
7. Spreadability test is performed on C. Disintegration
A. Ointments D. Dissolution
B. Creams
C. Suspensions 16. Exposure of bacterial plates in the production areas to
D. AOTA determine the microbiological load of each room is
A. Environmental monitoring
8. The type of ash where sulfuric acid is used B. Pollution monitoring
A. Acid insoluble ash C. Sterility testing
B. Sulfated ash D. Validation
C. Ignited ash
D. Loss on ignition

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17. To control raw materials in the warehouse of a company, 25. Ferrous sulfate is
the practice of ___________ is strictly followed A. An oxidizing agent
A. FIFO (first in, first out) B. A reducing agent
B. FILO (first in, last out) C. An agent that loses electrons
C. LIFO (last in, first out) D. B and C
D. LILO (last in, last out)
26. The moisture content of a drug may be
18. Measures designed to ensure stability and efficacy of a A. Water of hydration
drug product define B. Water in the absorbed form
A. Quality assurance C. Water of emulsion
B. Quality control D. A and B
C. Quality
D. Conformance 27. The titrant in non-aqueous alkalimetry
A. NaOH
19. To control microorganism in the air is to B. Perchloric acid
A. Install UV lamps in several areas C. Sodium methoxide
B. Provide ethylene oxide gas around the room D. Ammonium hydroxide
C. Install IR bulbs in the area
D. AOTA 28. Safety and toxicity tests for infusion plastic sets is
conducted using
20. A characteristic of indicator paper strips used during A. Rabbits
sterilization process is B. Dogs
A. Changes color in 121 degrees C C. White mice
B. Melts at 121 degrees C D. Guinea pigs
C. Destroyed at 121 degrees C
D. AOTA 29. The type of chromatography where the cellulose of the
filter paper is used as the adsorbent is
21. CGMP means A. Column
A. Current good manufacturing practice B. Gas
B. Current general manufacturing program C. Paper
C. Current general manufacturing practice D. TLC
D. Current good manufacturing program
30. Titer is an expression of concentration in terms of
22. A common sampling plan using master table to interpret A. gram of solute/100mL
results is B. gram of solute/L
A. 100% inspection C. g or mg of solute/mL
B. Square root system D. A and B
C. Military Standard 105-D
D. A and C 31. Microbiological assay of antibiotics may be performed by
using the following except
23. An analyst who determines the strength, potency and A. Test tube inoculation
percentage purity of a drug or pharmaceutical product is B. Cylinder plate method
performing C. Paper disc
A. Special method D. Staining method
B. ID test
C. Pharmaceutical assaying 32. Flame spectroscopy procedures are divided into
D. Pharmacopoeial test A. Flame emission
B. Atomic absorption
24. In azeotropic method of water analysis, the solvent used C. Nuclear magnetic resonance
may be D. A and B
A. Water
B. Toluene
C. Xylene
D. B and C

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33. High pressure liquid chromatography separations require 41. A place to perform experiments with obnoxious,
the following except suffocation fumes is
A. Column support as adsorbent A. Laminar flow hood
B. Internal standard B. Fume hood
C. Mobile phase of solvent C. HEPA filter
D. Nitrogen gas D. A and B

34. Two substances reacting upon reaching the end point 42. The resulting pattern with several bands in the process of
must have the same chromatography is
A. Normality A. Chromophore
B. Volume B. Chromatogram
C. Number of equivalents C. Rf value
D. Weight D. A and C

35. Which of the following is a reducing agent? 43. A law related to spectrometry where the power of
A. Ascorbic acid transmitted light decreases exponentially as the thickness of
B. Potassium permanganate the solution increases arithmetically is
C. Iodine A. Charle’s Law
D. Hydrochloric acid B. Beer’s Law
C. Lambert’s Law
36. One of the fundamental laws in spectrophotometry is D. Henry’s Law
A. Law of Mass Action
B. Beer’s Law 44. The endpoint in iodometry using starch TS as indicator is
C. Boyle’s Law A. Blue color
D. Newton’s Law B. Disappearance of blue color
C. Greenish blue color
37. In spectrophotometry procedure for assay, aside from the D. A and C
sample or unknown, this is required
A. Raw material of the sample 45. The assay of ascorbic acid content in hexavitamin
B. Reference standard capsules or tablets is by
C. Dosage form A. Use of iodimetric method
D. A and C B. Use of dye, dichlorophenol-indophenol
C. Permanganate method
38. Beer’s plot is spectrometry is prepared to determine D. A and B
A. Absorbance of the sample
B. Wavelength to be used 46. Adsorbent used as TLC, except
C. Blank A. Alumina
D. Concentration of the sample B. Silica gel
C. Calcium oxide
39. A unit of wavelength in spectrometry except D. Silica gel G
A. Nanometer
B. Micron 47. Expression of concentration in volumetric solutions,
C. Milliliter except
D. Micrometer A. Normality
B. Titer
40. In spectrometry procedure, a purpose of preparing a C. Molarity
spectral absorbance curve is D. Molality
A. To determine wavelength
B. To determine absorbance 48. The originators in volumetric precipitation assay
C. To determine transmittance procedures were introduced by the following scientists
D. To determine concentration except
A. Arrhenius
B. Mohr
C. Fajan
D. Volhard

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49. In nuclear magnetic resonance determination of a ANSWER KEY

substance, the following physical properties of nuclei as
A. Spin property 1. C 26. D
B. Nuclear magnetic moment 2. B 27. C
C. Volume of gas used 3. B 28. C
D. A and B 4. B 29. C
5. D 30. C
50. A substance which possesses the ability to react with 6. B 31. D
either acids or bases 7. A 32. D
A. Buffer 8. B 33. D
B. Catalyst 9. D 34. C
C. Amphoteric
10. A 35. A
D. Indicator
11. A 36. B
12. A 37. B
13. C 38.D
14. C 39. C
15. D 40. A
16. A 41. B
17. A 42. B
18. A 43. C
19. A 44. B
20. A 45. B
21. A 46. C
22. C 47. B
23. C 48. A
24. D 49. D
25. D 50. C

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SUPPLEMENTARY NOTES ON QUALITY CONTROL

TYPES OF CONTAINERS
SINGLE UNIT CONTAINER Designed to hold a quantity of drug product intended for administration as a single dose or
a single finished device intended for use promptly after the container is opened
SINGLE DOSE CONTAINER Single unit container for articles intended for parenteral administration only
UNIT DOSE CONTAINER Single unit container for articles intended for administration by other than the parenteral
route as single dose, direct from the container
MULTIPLE UNIT CONTAINER Permits withdrawal of successive portion of the contents without changing the strength,
quality or purity of the remaining portion
MULTIPLE DOSE CONTAINER Multiple unit container for articles intended for parenteral administration only
TAMPER RESISTANT Sealed that the contents cannot be used without obvious destruction of the seal
LIGHT RESISTANT Protects the contents from the effects of light by virtue of the specific properties of the
material of which it is composed, including any coating applied to it
WELL-CLOSED Protects contents from extraneous solids and from loss of article under the ordinary
customary conditions of handling, shipment, storage and distribution
TIGHT Protects contents from contamination by extraneous solids, liquids or vapors, from loss of
the article and from efflorescence, deliquescence or evaporation
HERMETIC Impervious to air or any gas under the ordinary or customary conditions of handling,
shipment, storage and distribution

STORAGE TEMPERATURE
FREEZER -20 to -10 °C
COLD 2-8 °C ; REFRIGERATOR
COOL 8-15 °C
ROOM TEMPERATURE TEMPERATURE PREVAILING IN
WORKING AREA
CONTROLLED ROOM 20-25 °C
TEMPERATURE
WARM 30-40 °C
EXCESSIVE HEAT ABOVE 40°C

TYPE OF GLASS
Type I HIGHLY RESISTANT BOROSILICATE GLASS
Type II TREATED SODA LIME GLASS
Type III SODA LIME GLASS
Type NP GENERAL PURPOSE SODA LIME GLASS

DISINTEGRATION
TEMPERATURE: 37 ± 2 (35-39°C)
STAGE N ACCEPTANCE
I 6 All should disintegrate within specified time limit
II +12 Not more than 2 of the 18 fail to disintegrate
completely within the specified time limit

DISSOLUTION
TEMPERATURE: 37 ± 0.5 (36.5-37.5°C)
STAGE N ACCEPTANCE
I 6 Each unit is not less than Q +5%
II +6 Average of 12 units tested is not less than Q; No unit is
less than Q-15
III +12 Average of 24 units is not less than Q; No more than 2
units are less than Q-15; No unit less than Q-25

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WAVELENGTHS
REGION WAVELENGTHS
FAR UV 100 - 200nm
UV 200 - 400nm
VISIBLE 400 - 750nm
NEAR IR 75nm - 4 um
FAR IR 4 – 25 um

FACTORS THAT ACCELERATE INSTABILITY

TEMPERATURE
LIGHT/RADIATION
MOISTURE
GRAVITY
AGITATION
METHOD OF MANUFACTURE
AIR
EXCIPIENT
PROCESSING MATERIALS
IMPURITIES
pH
HUMIDITY
ACTIVE INGREDIENT

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